Drugs

Horizon Misses on Lupus Phase 2 Endpoint

Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus (SLE) failed to show a statistically significant separation between daxdilimab and placebo on the primary endpoint. The company says the primary endpoint was the proportion of patients to achieve a British Isles Lupus Assessment Group (BILAG) 2004 Index-based Combined Lupus Assessment (BICLA) response and an oral glucocorticoid (OGC) dose of less than 7.5 mg/day (prednisone equivalent), which would represent a reduction from the baseline OGC dose at 48 weeks. BICLA is a composite measure indicating low SLE disease activity, it says, noting that numerical differences were seen in other endpoints. No safety concerns were reported in the study.

Daxdilimab is described by Horizon as an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. “Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in a variety of autoimmune conditions,” the company says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome